A San Francisco based biotech company is seeking a Senior Director of Regulatory Affairs Strategy & Submissions to join their growing team. This is a hybrid position, requiring 2-3 days onsite.
Responsibilities:
- Developing and executing regulatory strategies and operations to move products through all phases.
- Lead development of regulatory documentation
- Responsible for all regulatory interactions
- Provide regulatory support and guidance to other departments
- Manage the filing of all global regulatory submissions
- Contribute to preparation of IBs, CSRs, and other clinical documents such as clinical study protocols.
- Review all regulatory documents to ensure submission-readiness
- Vendor management
Requirements:
- Bachelor’s degree within science
- At least 10 years of experience
- Regulatory strategy & submissions experience
- Prior experience with expedited programs
- US and global experience
- Prior Leadership and Management experience
- Early to late stage clinical development experience and post approval experience
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
